Drug Regulatory Affairs
The Labeling Professionals
Project Management | Regulatory Intelligence
Mergers & Acquisitions | Training and Mentoring
SORAPEX stands for
SOnntag (the name of the founder and owner)
Regulatory Affairs (the field of expertise and services)
Pharmaceutical EXellence (the minimum standard of our work)
Professional
Degree in Pharmacy of Technische Universität Braunschweig and State examination and approbation as apothecary according to German legislation, both in 1991.
Additional diploma in Regulatory Affairs from Universiteit Leiden and Universiteit van Amsterdam in 1996.
Regular further training to keep up with the everchanging global / european regulatory affairs legislation and regulations.
Registered member of TOPRA (The Organisation of Professionals in Regulatory Affairs) and DGRA (Deutsche Gesellschaft für Regulatory Affairs).
Experienced
Nearly three decades in professional execution of projects regarding mainly European pharmaceutical regulatory affairs of human medicine products, including globally leading functions in regulatory affairs and labeling at large multinational pharmaceuticals.
Extensive knowledge in all labeling regarded tasks including
- management of labeling projects
- creation and admission of labeling documentation
- managing labeling inventory and conflicts at mergers & acquisitions
- training of management and office or technical personnel of labeling teams
- coaching and mentoring of labeling managers
- research of labeling information (labeling intelligence)
In Demand
History of more than 30 successfully executed projects in pharmaceutical regulatory affairs.
After creation of SORAPEX, Ltd. in 2012 at Richmond upon Thames, UK, the company was moved to Germany in 2016 and eventually incorporated as SORAPEX GmbH in 2019.
Succesfully enabling and helping large multinationals to small sized specialists in the pharmaceutical industry (please ask for details) to complete mainly labeling related regulatory affairs projects with emphasis on
- European region
- human medicinal products (drugs)
- project management
- training, coaching, mentoring
- mergers and acquisitions
- regulatory intelligence